Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Takeda has a strong heritage in the discovery of new medicines and continues to invest in research & development capabilities that produce medicines for patients with unmet medical needs.
We are looking for a strong candidate for the position of Medical Adviser. This position reports to the Medical Lead.
The primary role objectives of the Medical Advisor are to act as a strategic scientific expert, facilitate evidence generation, exchange scientific information, build strategic partnerships, initiate patient related activities, develop organizational capabilities and enhance compliance and ethics.
Act as strategic scientific expert
Is an active participant in cross-functional teams (including Brand-, Launch- and Launch Preparation- and Account Teams as appropriate), contributes to strategy and activities.
Develops Medical Plan(s) in line with and to strengthen the overall internal Brand/Launch/Account Plan(s).
Translates scientific knowledge and insights about disease and treatment landscape into strategies and practical application.
Provides scientific support to internal stakeholders (including marketing, market access, sales) through training and ad-hoc support.
Supports Market Access in dossier creation and discussion with Market Access stakeholders.
Develops materials for exchange of scientific information.
Act as the Medical Affairs liaison with EUCan and other LOCs.
Facilitate evidence generation
Respond to requests from HCPs for Investigator Initiated Studies / Collaborative Clinical Research (IISs/CCRs) in line with company procedure
Coordinates process around IISs/CCRs (contracts, budget, timelines).
(Co-)designs local Company Initiated Study protocols and evidence generation strategies
Supervises local Company Initiated Studies (contracts, budget, timelines).
Support ongoing and future global company sponsored clinical studies according to the collaboration model with Clinical Operations and CROs established by the company.
Ensures specific local evidence needs are being considered by the global teams to be incorporated in global company sponsored clinical studies.
Has knowledge of and is compliant with laws and regulations regarding studies (GCP, GDPR, WMO etc.).
Contributes to the generation of Real World Evidence and Value Based Healthcare together with internal and external stakeholders.
Exchange scientific information
Present medical data to key stakeholders in the most efficient way (e.g. through Omni Channel Engagement) leveraging understanding of their unmet needs
Leverage scientific and medical discussions to deepen focus on defining clinical treatment pathways
Organizes and leads scientifically relevant (national) advisory boards.
Develops (inter)national accredited CME activities for health care professionals, together with the relevant medical experts.
Is aware of the processes related to Adverse Events. Signals, analyzes and acts on safety signals, deepens them during interactions and reports them within the set time in accordance with legislation and regulations and company SOPs.
Build strategic partnerships
Perform mapping and profiling of relevant external experts (e.g. KOLs) and stakeholders in current and future therapeutic areas of interest
Build and maintain sustained and trusted partnerships with external experts and stakeholders
Seek, collect, organize and share scientific insights about key strategic questions, gaps and projects
Process external requests for medical sponsorships and grants (HCP, HCO)
Understand the patient journey and provide insights to support medical and scientific strategy development
Initiate patient related activities
Set up and supervise compassionate use, named patient and early access programs, including scientific assessment of patient inclusion.
Provides scientific support to Patient Support Programs (PSP).
Has scientific input in patient information material.
Develop organizational capabilities
Develop and maintain state-of-the-art expertise on key capabilities as allocated (e.g. Evidence Generation & Management (EGM), New Product Planning (NPP), Omni Channel Engagement (OCE) and/or Continuous Medical Education (CME), in order to act as a champion/ambassador for growing these capabilities on an organizational level.
Enhance compliance and ethics
Has knowledge of, is compliant with and has a role model function in the filed of legislation and regulations (CGR, Medicines Act, GDPR)
Is responsible for review of (non) promotional materials on medical scientific content/compliance.
Reviews Medical Affairs related SOPs.
Reviews and approves cross-border Health Care Provider fee-for-service activities and agreements (GEARS).
Your SKILLS and COMPETENCIES
Critical Skills and Competencies
Knowledge and science: In-depth and up-to-date knowledge of healthcare in general and therapeutic areas in particular. Ability to apply this and place it in context. Profound understanding of compliance and medical ethics.
Communication: Advanced communication skills to build and shape internal and external relationships during interactions impactful. Advance Medical Department visibility within the organization.
Collaboration and Partnership: Establishes productive relationships and partners with others across the organization to ensure common understanding of objectives and achieve shared goals. Engages in internal and external partnerships through a structured and collaborative approach.
Strategy and Planning: Ability to establish a holistic understanding of the big picture, to anticipate long-term developments, to recognize trends and to think in scenarios.
Entrepreneurship: Pro-actively identifies/creates opportunities in order to add value for patients, health care professionals and the internal organization. Takes calculated risks to achieve goals.
Agile way of working: Able to find the most appropriate and effective way to carry out a particular task to optimize performance: with maximum flexibility and minimum constraints. Display an attitude and behaviour of curiosity and empowered pro-activity to find solutions and take decisions. Active participation in fit for purpose teams throughout the organizational matrix.
Organisational sensitivity: Savvy in understanding and sensing the formal and informal corporate culture. Creates genuine win-win solutions.
Social responsibility: Acts in the interest of the patient, his/her environment and society. Has a strong ethical compass. Ability to navigate in complex situations balancing SOPs, regulations, our values and business interests.
Experience and Education
Minimum of MSc (MD, PharmD, or PhD preferred) in biomedical sciences or related degree in biological sciences
3+ years experience in (bio)pharmaceutical Medical Affairs (a Clinical Research environment is also acceptable)
A good understanding of clinical development and clinical study design
Experience of working in a cross functional environment
You must be fluent in Dutch and English
Willingness to be 50% of the time on the road (field or with external stakeholders (e.g virtual engagements)